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Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

NCT01294410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2015-06-25

No results posted yet for this study

Summary

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Placebo

Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks

DRUG

Placebo

Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days

DRUG

Anti-IP-10 Antibody

Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks

DRUG

Anti-IP-10 Antibody

Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks

DRUG

Anti-IP-10 Antibody

Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days

DRUG

Anti-IP-10 Antibody

Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days

DRUG

Anti-IP-10 Antibody

Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days

DRUG

Anti-IP-10 Antibody

Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-12-31
Completion
2014-12-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01294410 on ClinicalTrials.gov